Healthy Skepticism Library item: 15749

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Goozner M.
FDA Takes New Look at DTC Drug Ads
GoozNews 2009 Jun 1
http://www.reducedrugprices.org/read.asp?news=3718

Full text:

Two weeks ago, the Food and Drug Administration accused Johnson & Johnson of running a misleading online video ad for its chronic pain medication Ultram ER. In the warning letter, the agency complained that the drug’s risks, which include seizures, the potential for overdose and withdrawal symptoms, did not appear until the last minute of the seven-minute video. Moreover, the risks were “presented in a telescript format, with rapidly scrolling text in small type font, and with no accompanying audio presentation,” the letter said. J&J immediately pulled the ad.

The Ultra ER warning letter is a good example of the more aggressive policing of direct-to-consumer (DTC) ads that industry can expect from the Division of Drug Marketing, Advertising and Communications (DDMAC) under the FDA’s new leadership team. It will no longer suffice to append small-type warnings about the risks of a particular prescription drug to a DTC ad. The warnings must be given equal prominence to the drug’s benefits, and done in a way that does not hide the message.

Last week, the agency released a draft guidance with its latest advice on how companies can comply with the laws governing DTC advertising. The guidance not only asks for balance between risk and benefits information contained in the ads, but it detailed a long list of dos and don’ts to ensure the risk part of the equation is effectively communicated. The draft went so far as to offer advice on the use of headlines, bold-faced type and capital letters. The proposal is now open for comment here.

The proposed guidance doesn’t have the force of regulation, but clearly marks a sharp shift from the FDA’s last offering on the subject in 2004. In that document, drafted before Vioxx was withdrawn from the market, the FDA encouraged plain language warnings and said they should be given prominence within the main part of the ads (not just in the small text ads that usually followed on another page of print ads). But it threw up its hands at how that might be achieved. “We have not evaluated how presenting the information in different formats affects consumer comprehension, and we believe that there is much to be learned before we develop final guidance on how best to inform patients about the drugs being promoted,” the 2004 draft guidance said.

When the Pharmaceutical Research and Manufacturers Association issued voluntary guidelines in 2005, it also ignored specific formatting issues. “Risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals,” the trade group suggested. Despite those voluntary guidelines, “omission or minimization of risk information is the most frequent violation of the regulations cited in advertising and promotion enforcement letters sent to sponsors,” the latest FDA draft guidance noted.

The FDA staffers at DDMAC clearly did their homework before issuing the new proposal. One article cited in the guidance bore this title: “Quantifying and predicting the effects of basic text display variables on the perceived urgency of warning labels: Tradeoffs involving font size, border weight, and color.”

They also spent a lot of time evaluating visual elements that might distract viewers from comprehending risk messages in broadcast ads. “This distraction could be caused by factors including busy scenes, frequent scene changes, moving camera angles, and even inherently compelling, vivid visuals,” the guidance said.

And who hasn’t seen television drug ads where the announcer listing the side effects sounded as if he was an auctioneer at a home foreclosure? Such tactics will no longer pass muster, according to the latest guidance.

A critical speech consideration is pacing. If risk information is considerably more difficult to hear and process than benefit information because it is presented at a much faster pace, the piece will not convey an accurate impression of the product.

Publication of the draft guidance won’t change much for many firms. It’s been in the works for a while, and major companies have been working with DDMAC to bring their print and broadcast ads into compliance. The latest Atlantic Magazine, for instance, contains a two-page spread for Pfizer’s Lipitor, where half the first page and all of the second page contain a straightforward explanation of who should or shouldn’t take the drug, possible side effects and a phone number where consumers can report them.

But, as the J&J warning letter suggests, the Internet presents a major enforcement problem. It offers manufacturers an endless space for potentially misleading drug advertising, which will take a lot of time and manpower to police. One option is to ask manufacturers to submit their Internet promotional materials (and websites) to DDMAC for review. PhRMA’s guidelines recommended that course for broadcast advertising. It would help the agency if firms did the same for their online advertising.